The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
242
High
453
Moderate
173
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 23% are Severe.

Which agencies issued them

1001–1035 of 1035

  • ModerateFDA (Devices)·Z-2897-2016·2016-10-05

    Prismatik Recalls BruxZir Shaded Dental Restorations Due to Quarantine Failure

    Prismatik Dentalcraft is recalling 150 units of BruxZir Shaded dental restorations because the manufacturer failed to properly identify quarantined lots as such.

    Product
    BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2016·2016-10-05

    Siemens Syngo.plaza PACS Software Recall for Multiple Issues

    Siemens Medical Solutions is recalling 47 Syngo.plaza Picture Archiving and Communication System units to address several software issues.

    Product
    Syngo.plaza, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1522-2016·2016-10-05

    Pharmatech Recalls Ninjacof-A Liquid Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling Ninjacof-A liquid due to a potential risk of contamination with B. cepacia bacteria. This is a precautionary measure.

    Product
    Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2620-2016·2016-10-05

    Triana Family Brioche Donuts Recalled for Undeclared Food Dyes

    PAO DE MILHO III, LLC is recalling Triana Family Brioche Donuts Bavarian Cream because they contain undeclared FD&C Yellow #5 and FD&C Yellow #6.

    Product
    Triana Family Brioche Donuts Bavarian Cream Net Wt. 0.75 LBS (340 g) 12 -24 Jabez St., Newark, NJ 07106 UPC 000260003995 packaged in a clear plastic clam shell container
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2889-2016·2016-10-05

    Ethicon Mersilene Tape Recalled for Incorrect Instructions for Use Insert

    Ethicon, Inc. is recalling Mersilene Tape products because certain product codes were supplied with an incorrect Instructions for Use (IFU) insert.

    Product
    ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2623-2016·2016-10-05

    Jake's Candy Gummy Worms Recalled for Undeclared Artificial Colors

    Four Brothers Packaging is voluntarily recalling Jake's Candy Gummy Worms because the product contains undeclared artificial colors Red 40, Yellow 6, and Blue 1.

    Product
    Jakes Candy Gummies Worms. o Product label(s): ***Jakes Candy *** GUMMIES WORMS *** Net Wt. 1.1 oz. *** Exp. 12/2020 *** INGREDIENTS: Corn syrup, sugar, citric acid, natural and artificial flavors, artificial colors, including FD&C #5. *** 12 bags per case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2602-2016·2016-10-05

    Goya Honey with Comb Recalled for Unregistered Chemical Presence

    Tradewind Foods is recalling Goya Honey with Comb because FDA testing found 2,6-Dichlorobenzamide, a chemical not registered for use in honey.

    Product
    Label reads in part as " GOYA ***HONEY WITH COMB***PURE ALL NATURAL***NET WT. 16 OZ (1LB)***15173***GOYA FOODS, INC. SECAUCUS, NJ 07096"
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2884-2016·2016-10-05

    Microgenics Recalls DRI Salicylate Serum Tox Assay Due to Sensitivity Issues

    Microgenics Corporation is recalling specific lots of DRI Salicylate Serum Tox Assay kits because negative patient samples are recovering higher than the product's sensitivity claim.

    Product
    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2887-2016·2016-10-05

    R&D Systems Recalls Quantikine IVD sTfR Immunoassay Kits Due to Control Issues

    R&D Systems is recalling 725 Quantikine IVD sTfR Immunoassay Kits because internal testing confirmed that control results were out of range high.

    Product
    R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-1526-2016·2016-10-05

    Pharmatech Recalls Senna Syrup Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling Senna Syrup due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2016·2016-10-05

    Siemens ADVIA Centaur Calibrator U Recalled for Analytical Sensitivity Failure

    Siemens is recalling ADVIA Centaur Calibrator U kits due to failure of analytical sensitivity and drift from internal standardization.

    Product
    Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1524-2016·2016-10-05

    Pharmatech Recalls Diocto Syrup Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling Diocto Syrup (docusate sodium) nationwide due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2622-2016·2016-10-05

    Jake's Candy Recalls Jelly Fruit Slices for Undeclared Food Dyes

    Four Brothers Packaging is recalling Jake's Candy Assorted Jelly Fruit Slices because the product contains undeclared FD&C colors Yellow 5 and Blue 1.

    Product
    Jakes Candy Assorted Jelly Fruit Slices, Product label(s):***Jakes Candy *** ASST. JELLY FRUIT SLICES *** Net Wt. 3.5 oz. *** INGREDIENTS: Corn syrup, sucrose, corn starch, natural flavor, red #3, red #40, yellow #6. 12 bags per case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2892-2016·2016-10-05

    Siemens Medical Solutions Recalls Syngo.plaza VB10A Picture Archiving Systems

    Siemens Medical Solutions USA, Inc. is recalling 47 Syngo.plaza VB10A Picture Archiving and Communication Systems to eliminate several software issues.

    Product
    Syngo.plaza VB10A, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1550-2016·2016-10-05

    Mckesson Recalls Mislabeled Lansoprazole Capsules Due to Labeling Error

    Mckesson Packaging Services is recalling 181 cartons of Lansoprazole capsules due to a label mix-up where the outer packaging was mislabeled.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2621-2016·2016-10-05

    Jake's Candy Recalls Starlight Kisses Mints for Undeclared Dyes

    Four Brothers Packaging is voluntarily recalling Jake's Candy Assorted Starlight Kisses Mints because the product contains undeclared FD&C colors Red 40, Blue 1, and Red 3.

    Product
    Jakes Candy Assorted Starlight Kisses, Product label(s):***Jakes Candy *** ASST. STARLIGHT KISSES *** Net Wt. 1.5 oz. *** Exp. 7/2019 *** INGREDIENTS: Corn syrup, citric acid, natural and artificial flavor, artificial flavors may contain citric acid or including FD&C yellow 5
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2890-2016·2016-10-05

    EKOS Corporation Recalls EKOS Carts Due to Missing Wheel Washers

    EKOS Corporation is recalling 455 EKOS carts because missing washers may cause wheels to wear or dislodge, leading to equipment failure.

    Product
    The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1523-2016·2016-10-05

    Pharmatech Recalls Aller-Chlor Syrup Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling 12,308 bottles of Aller-Chlor Syrup nationwide due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2016·2016-10-05

    Beckman Coulter Recalls AQUIOS CL Flow Cytometers Due to Carousel Misalignment

    Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the reagent carousel can misalign and damage the prep probe.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-1519-2016·2016-10-05

    Unichem Recalls Lamotrigine Tablets With Incorrect Imprint

    Unichem Pharmaceuticals is recalling 368 bottles of Lamotrigine 150 mg tablets because they have the wrong imprint. The FDA classifies this as Class III.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1527-2016·2016-10-05

    Mckesson Recalls Xanax Tablets Due to Missing Primary Packaging Labels

    Mckesson Packaging Services is recalling 3,492 cartons of Xanax (Alprazolam) 0.5 mg tablets because the primary blister card labels are blank and lack product information.

    Product
    Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10
    Category
    Drug
    Distribution
    4 states
  • HighCPSC·17006·2016-10-04

    Office Depot Recalls Winsley Mid-Back Chairs Due to Fall Hazard

    Office Depot is recalling Winsley Mid-Back Chairs because they can tip over when users lean back, posing a fall hazard. No injuries have been reported.

    Product
    Winsley Mid-Back Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17003·2016-10-04

    Sargent Art Recalls Tempera and Finger Paints Due to Bacteria Risk

    Sargent Art is recalling 13 types of tempera and finger paints due to potential harmful bacteria. Consumers should stop using the products and contact the company for a refund.

    Product
    Arts and crafts tempera and finger paints
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17004·2016-10-04

    Interlogix Recalls Wireless Personal Panic Devices Due to Operational Failure

    Interlogix is recalling about 67,000 wireless personal panic devices because they may fail to operate during an emergency. Consumers should contact their security installer for a free inspection and replacement.

    Product
    Interlogix ® wireless personal panic devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V708000·2016-10-04

    REV Recalls 2010-2016 Road Rescue Vehicles Due to Touchscreen Software Defect

    REV is recalling 2010-2016 Road Rescue and other emergency vehicles because touchscreen software may cause accessories to turn on or off unexpectedly, increasing crash risk.

    Product
    ROAD RESCUE — ROAD RESCUE SPECIALTY VEHICLE, ULTRAMEDIC, TRANSMEDIC, DURAMEDIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·092-2016·2016-10-03

    Daily's Premium Meats Recalls Precooked Bacon Due to Listeria Risk

    Daily's Premium Meats is recalling approximately 170 pounds of precooked bacon products due to possible Listeria monocytogenes contamination. The products were distributed to retail locations in Idaho and Utah.

    Product
    Daily's Premium Meats, LLC — Daily's Premium Meats, LLC Recalls Bacon Products Due to Possible Listeria Adulteration
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V705000·2016-10-03

    Kia Recalls 2016 Optima Vehicles Due to Front Axle Driveshaft Defect

    Kia is recalling 12,214 model year 2016 Optima vehicles because the right front axle driveshaft may crack and fail, potentially causing the vehicle to stop moving or roll unexpectedly.

    Product
    KIA — KIA OPTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide

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